Progressive Regulatory management experience in IVD, featuring a proven track record of filings (510ks, PMAs, IDEs, global dossiers, and registrations), direct negotiations with the US FDA and global regulators, and active leadership within the broader regulatory community (e.g., CDRH, RAPs, MDIC, AdvaMed). Strong leadership experience, preferably with extensive experience of building and leading diverse, global teams, and/or matrix leadership of enterprise-level technology-based projects in relevant areas.